- Eisai, Inc (Baltimore, MD)
- …a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position ... design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit...US FDA, PMDA, ICH). Essential Functions Independently conduct audits Review and oversee results of CQA audits of study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …organization. This will include providing innovative strategies to continuously improve Global Clinical Operations quality and metrics. IT will also include ... plans for their teams with the CROs. Responsible to review metrics and issues for their studies and ensure...quality measures. Analyze CRO performance trends within a clinical study or across several studies and resolve or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... of regulatory guidelines across all manufacturing areas, supporting both clinical and commercial sites. This individual will be a...and gathering of quality metrics for Legend's Quality Management Review (QMR).Support management of the… more
- Merck & Co. (Rahway, NJ)
- …for clinical supplies. Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address ... supply chain deliverables and prepares, analyses, and/or develops mitigation strategies for review with clinical partners and senior leaders. Works directly in… more
- Insmed Incorporated (NJ)
- …through Phase 3, ensuring compliance with GMPs and internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including ... Regulatory, Clinical Operations, and Program Management to drive proactive Quality input into development programs.Provide Quality oversight of contract… more
- Insmed Incorporated (NJ)
- …role will support implementation and ongoing management of digital systems used in clinical trial operations, quality control laboratories and other GxP areas, ... Good Clinical Practice (GCP) E6(R3), Computerized Systems Used in Clinical Trials, Computer System Validation, Quality Management Systems ProcessesWho You… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …acquisition, validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements ... acceptance and reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements.Oversees… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , technical ... personnel to provide guidance and determine immediate path forward for manufacturing quality issues. Review of all documentation, in accordance with Good… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... QA Document Control Specialist I/II/III as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment.… more
- InterDent (Portland, OR)
- …emphasizing prevention and long-term wellness. As the RCD/DD, you will champion clinical quality , mentor and develop clinicians, and align practice performance ... such as Gentle Dental and Blue Oak Dentalare dedicated to delivering high- quality , patient-centered care through modern technology, clinical excellence, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... seeking QA Investigations Lead III as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment.… more
- Insmed Incorporated (NJ)
- …internal and external partners. This individual will be responsible as a medical reviewer for the medical and commercial review committees.What You'll Do: ... received by MI staff are forwarded to Insmed's Pharmacovigilance and/or Quality Assurance Department, respectivelyMedical Information - Medical Reviewer :Medical … more
- Merck & Co. (Rahway, NJ)
- … Clinical Trial Operations (GCTO) Regional colleagues and Global - Development Quality (GDQ) to address clinical supply related topics. - Responsible and ... supply chain deliverables and prepares, analyzes, and/or develops mitigation strategies for review with clinical partners and senior leaders. - Responsible and… more
- Insmed Incorporated (NJ)
- …and cross functional teams. This individual will provide scientific support to clinical development and operations, regulatory and quality assurance teams, as ... to: Collaborate with internal teams, CROs, and external vendors to prepare, review , and finalize clinical protocol documents.Contribute to scientific and… more
- Genmab (NJ)
- …experience.Supports high- quality clinical trial conduct and relationship quality through ongoing review , identification and resolution of issues and ... teams and relevant stakeholders to obtain in-depth requirements to support efficient review of the conduct, quality and integrity of the… more
- Insmed Incorporated (San Diego, CA)
- …be responsible for the development and implementation of EDC systems to support clinical trials, ensuring data quality , compliance, and efficiency throughout the ... data systems. The candidate will collaborate closely with the Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to ensure departmental KPIs and regulatory compliance are consistently met Implement Medical Review Prospective & Retrospective Quality Review of cases ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (Rahway, NJ)
- …internal and external R& D collaborations to enable innovative strategies for clinical trial biomarker testing. Author and review internal technical reports ... Molecular Biomarkers (TMB) is responsible for translating preclinical molecular biomarkers into clinical development across all therapeutic areas and all phases of … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....in Patient Safety including, but not limited to contract review and vendor management support in regard to safety… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …during clinical trials to ensure participant safety and data integrity. Review and interpret safety signals, adverse events, and efficacy data in collaboration ... OverviewThe Respiratory Clinical Development Medical Lead will oversee the ...knowledge of regulatory frameworks (eg, FDA), GCP guidelines, and quality management systems.Preferred but Not Mandatory: Medical practice experience… more
